Phase 1 Trial: Fortrea
| ISRCTN | ISRCTN40371122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40371122 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1006698 |
| Protocol serial number | IRAS 1006698 |
| Sponsor | JAZZ Pharmaceuticals Research UK Ltd |
| Funder | JAZZ Pharmaceuticals Research UK Ltd |
- Submission date
- 26/06/2024
- Registration date
- 27/06/2024
- Last edited
- 27/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Public, Scientific
3170 Porter Drive
Palo alto
94304
United States of America
| ClinicalTrialDisclosure@jazzpharma.com |
Principal investigator
Drapers Yard, Marshall Street
Leeds
LS11 9EH
United Kingdom
| Phone | +441133013644 |
|---|---|
| jim.bush@fortrea.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I safety tolerability and pharmacokinetics in 96 healthy volunteers |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Phase 1 Trial: Fortrea |
| Study objectives | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) |
1. Approved 19/01/2023, London-Brent Research Ethic Committee (80 London Road, Skipton House, London, SE1 6LH, United Kingdom; +44 (0)20 3080 6456; brent_rec@hra.nhs.uk), ref: 22/LO/0850 2. Approved 07/03/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6456; clintrialhelpline@mhra.gov.uk), ref: CTA 36772/0031/001-0001 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Primary outcome measure(s) |
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key secondary outcome measure(s) |
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Completion date | 12/01/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 96 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 18/04/2023 |
| Date of final enrolment | 12/01/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Holbeck
Leeds
LS11 9EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of nontherapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/06/2024: Study's existence confirmed by Health Research Authority (HRA) London-Brent Research Ethic Committee.
